JP6402191B2 - コリンアルホスセラートを含有するフィルムコーティング錠剤およびその製造方法 - Google Patents
コリンアルホスセラートを含有するフィルムコーティング錠剤およびその製造方法 Download PDFInfo
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- JP6402191B2 JP6402191B2 JP2016540587A JP2016540587A JP6402191B2 JP 6402191 B2 JP6402191 B2 JP 6402191B2 JP 2016540587 A JP2016540587 A JP 2016540587A JP 2016540587 A JP2016540587 A JP 2016540587A JP 6402191 B2 JP6402191 B2 JP 6402191B2
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- weight
- film
- choline
- tablet
- film coating
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 title claims description 60
- 229960001231 choline Drugs 0.000 title claims description 60
- 239000007941 film coated tablet Substances 0.000 title claims description 39
- 238000004519 manufacturing process Methods 0.000 title claims description 27
- 239000003826 tablet Substances 0.000 claims description 72
- 239000007888 film coating Substances 0.000 claims description 69
- 238000009501 film coating Methods 0.000 claims description 69
- 239000010410 layer Substances 0.000 claims description 52
- 238000000576 coating method Methods 0.000 claims description 34
- 239000011248 coating agent Substances 0.000 claims description 29
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 28
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 26
- WMGSQTMJHBYJMQ-UHFFFAOYSA-N aluminum;magnesium;silicate Chemical compound [Mg+2].[Al+3].[O-][Si]([O-])([O-])[O-] WMGSQTMJHBYJMQ-UHFFFAOYSA-N 0.000 claims description 26
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 24
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 24
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 23
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 23
- 239000000203 mixture Substances 0.000 claims description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims description 15
- 239000000654 additive Substances 0.000 claims description 14
- 239000008187 granular material Substances 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 13
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 13
- 230000000996 additive effect Effects 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 9
- 238000005550 wet granulation Methods 0.000 claims description 9
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 8
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 8
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 8
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 7
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 7
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- 238000000034 method Methods 0.000 claims description 7
- 239000012046 mixed solvent Substances 0.000 claims description 7
- 239000004480 active ingredient Substances 0.000 claims description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 6
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 5
- 239000007884 disintegrant Substances 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 claims description 3
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 3
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 3
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 3
- 239000000314 lubricant Substances 0.000 claims description 3
- 235000019359 magnesium stearate Nutrition 0.000 claims description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
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- 229940079832 sodium starch glycolate Drugs 0.000 claims description 2
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- 239000000243 solution Substances 0.000 description 20
- 239000007901 soft capsule Substances 0.000 description 14
- 238000009472 formulation Methods 0.000 description 11
- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 8
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
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- HMUNWXXNJPVALC-UHFFFAOYSA-N 1-[4-[2-(2,3-dihydro-1H-inden-2-ylamino)pyrimidin-5-yl]piperazin-1-yl]-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethanone Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)N1CCN(CC1)C(CN1CC2=C(CC1)NN=N2)=O HMUNWXXNJPVALC-UHFFFAOYSA-N 0.000 description 4
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- OIPILFWXSMYKGL-UHFFFAOYSA-N acetylcholine Chemical compound CC(=O)OCC[N+](C)(C)C OIPILFWXSMYKGL-UHFFFAOYSA-N 0.000 description 2
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- YLZOPXRUQYQQID-UHFFFAOYSA-N 3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)-1-[4-[2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidin-5-yl]piperazin-1-yl]propan-1-one Chemical compound N1N=NC=2CN(CCC=21)CCC(=O)N1CCN(CC1)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F YLZOPXRUQYQQID-UHFFFAOYSA-N 0.000 description 1
- 206010054196 Affect lability Diseases 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- 108010009685 Cholinergic Receptors Proteins 0.000 description 1
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- 108010010803 Gelatin Proteins 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 206010061285 Mental disorder due to a general medical condition Diseases 0.000 description 1
- AFCARXCZXQIEQB-UHFFFAOYSA-N N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CCNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 AFCARXCZXQIEQB-UHFFFAOYSA-N 0.000 description 1
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- 235000010724 Wisteria floribunda Nutrition 0.000 description 1
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- JAUGGEIKQIHSMF-UHFFFAOYSA-N dialuminum;dimagnesium;dioxido(oxo)silane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[Mg+2].[Mg+2].[Al+3].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O JAUGGEIKQIHSMF-UHFFFAOYSA-N 0.000 description 1
- PGZIKUPSQINGKT-UHFFFAOYSA-N dialuminum;dioxido(oxo)silane Chemical compound [Al+3].[Al+3].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O PGZIKUPSQINGKT-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- Public Health (AREA)
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- Inorganic Chemistry (AREA)
- Neurosurgery (AREA)
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- Biomedical Technology (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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| Application Number | Priority Date | Filing Date | Title |
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| KR10-2013-0157198 | 2013-12-17 | ||
| KR1020130157198A KR101556568B1 (ko) | 2013-12-17 | 2013-12-17 | 콜린 알포세레이트를 함유하는 필름코팅정 및 이의 제조방법 |
| PCT/KR2014/012320 WO2015093796A1 (en) | 2013-12-17 | 2014-12-15 | Film coated tablet containing choline alfoscerate and process for preparing the same |
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| Publication Number | Publication Date |
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| JP2017504596A JP2017504596A (ja) | 2017-02-09 |
| JP6402191B2 true JP6402191B2 (ja) | 2018-10-10 |
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| EP (1) | EP3082776B1 (es) |
| JP (1) | JP6402191B2 (es) |
| KR (1) | KR101556568B1 (es) |
| CN (1) | CN105658208B (es) |
| ES (1) | ES2665775T3 (es) |
| PH (1) | PH12016500626B1 (es) |
| RU (1) | RU2669351C1 (es) |
| WO (1) | WO2015093796A1 (es) |
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| CN109539334B (zh) * | 2015-03-10 | 2020-06-19 | 松下知识产权经营株式会社 | 加热烹饪器 |
| KR101796628B1 (ko) * | 2016-05-25 | 2017-11-10 | 한국프라임제약주식회사 | 콜린알포세레이트를 함유하는 방습성 정제, 및 이의 제조방법 |
| KR101898669B1 (ko) | 2017-02-15 | 2018-10-31 | 콜마파마(주) | 콜린알포세레이트 함유 캡슐제 및 이의 제조방법 |
| KR102148374B1 (ko) * | 2018-11-21 | 2020-08-27 | 삼익제약주식회사 | 콜린알포세레이트를 포함하는 이층 코팅 정제 및 이의 제조 방법 |
| CN112137971A (zh) * | 2019-06-28 | 2020-12-29 | 北京万全德众医药生物技术有限公司 | 一种甘磷酸胆碱的口腔崩解片及其制备方法 |
| JP7366612B2 (ja) * | 2019-07-09 | 2023-10-23 | 東和薬品株式会社 | レボカルニチンを含有する錠剤 |
| KR102428859B1 (ko) | 2020-05-29 | 2022-08-04 | 동성제약주식회사 | 안전성이 확보된 소화기계 질환 예방 또는 치료를 위한 경구투여용 약학 조성물 |
| CN113041252A (zh) * | 2021-03-22 | 2021-06-29 | 上海欧睿生物科技有限公司 | 一种具有优异抗吸湿性的Alpha-GPC配方工艺技术 |
| CN114452807B (zh) * | 2021-12-29 | 2023-05-02 | 深圳华明环保科技有限公司 | 一种干法脱硝剂及其制备方法 |
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| CN1976751A (zh) * | 2004-06-28 | 2007-06-06 | H.隆德贝克有限公司 | 释放化学物质的多孔物品 |
| WO2008148798A2 (en) * | 2007-06-04 | 2008-12-11 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
| BRPI0812964A2 (pt) * | 2007-06-25 | 2014-12-16 | Tibotec Pharm Ltd | Forma de dosagem farmacêutica oral sólida |
| KR101499533B1 (ko) | 2008-02-15 | 2015-03-09 | 주식회사 씨티씨바이오 | 콜린 알포세레이트 함유 약학 제제 |
| WO2010006697A2 (en) * | 2008-06-30 | 2010-01-21 | Tibotec Pharmaceuticals | Powders for reconstitution |
| JP5827952B2 (ja) * | 2009-10-09 | 2015-12-02 | ユンジン・ファーム・カンパニー・リミテッドＹｕｎｇｊｉｎ Ｐｈａｒｍ． Ｃｏ． Ｌｔｄ． | 速効性と持続性を同時に有する薬剤学的組成物 |
| KR101172699B1 (ko) * | 2011-05-16 | 2012-08-09 | 한국프라임제약주식회사 | 콜린알포세레이트를 함유하는 약학 제제, 및 그의 제조방법 |
| KR101257919B1 (ko) * | 2011-07-14 | 2013-04-30 | 주식회사 바이오파마티스 | 콜린 알포세레이트 또는 이의 약학적으로 허용되는 염을 포함하는 경구용 고형 제제 및 이의 제조방법 |
| CN102525992A (zh) * | 2012-03-09 | 2012-07-04 | 徐奎 | L-α-甘油磷酸胆碱薄膜衣片及其制备方法 |
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|---|---|
| US9782353B2 (en) | 2017-10-10 |
| EP3082776B1 (en) | 2018-03-28 |
| KR20150070694A (ko) | 2015-06-25 |
| CN105658208B (zh) | 2019-05-03 |
| CN105658208A (zh) | 2016-06-08 |
| PH12016500626A1 (en) | 2016-05-30 |
| EP3082776A1 (en) | 2016-10-26 |
| RU2669351C1 (ru) | 2018-10-10 |
| JP2017504596A (ja) | 2017-02-09 |
| KR101556568B1 (ko) | 2015-10-01 |
| PH12016500626B1 (en) | 2016-05-30 |
| ES2665775T3 (es) | 2018-04-27 |
| WO2015093796A1 (en) | 2015-06-25 |
| EP3082776A4 (en) | 2017-07-26 |
| US20170027875A1 (en) | 2017-02-02 |
| RU2016128216A (ru) | 2018-01-23 |
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